Last week the US FDA announced a new web page setting out its current Small Business Program. This program provides fee breaks for small businesses seeking FDA regulatory approvals. The fee breaks are substantial (up to 75% off) and a business doesn’t have to be all that small to qualify. Non US businesses can apply too.
Businesses wishing to market Class II Medical devices (or certain Class I and III) or IVDs in the USA are required to obtain premarket clearance through the 510(k) notification process.
When you’re considering the US market for your product, you may have spent hours browsing through the internet, reading through mountains of regulations, guidance documents and standards, researched published white papers and yet… you’ve not been able to answer one fundamental question, “Do you have the right 510(k) strategy?”
Innovative Pathways for fast track approval of new technologies are continually in the news. These pathways attempt to serve industry development goals in the guise of meeting unmet clinical needs. Still it’s a laudable goal. But are these programmes effective? or safe?
US FDA this week backed away from proposals to directly regulate Lab Developed Tests, signalling an increased caution ahead of the new administration. But FDA has also said it intends to bring forward further proposals soon – and what does this mean for manufacturers seeking to market tests through LDT?
The US FDA has amended the definition of custom medical devices to improve industry compliance. The updated definition seeks to clarify a 2014 guidance after it became apparent that some manufacturers were distributing medical devices as custom devices despite not meeting the statutory requirements.
We get excited by our clients successes, especially with truly breakthrough innovations. We are delighted to congratulate the team at LBT Innovations in achieving US FDA clearance for their revolutionary APAS technology.